Patent: 9,309,316

Summary for Patent: 9,309,316

Title:	Stable subcutaneous protein formulations and uses thereof
Abstract:	The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.
Inventor(s):	Dali; Manisha D. (Bridgewater, NJ), Dahlheim; Charles E. (Lawrenceville, NJ), Borsadia; Sunita (Plainsboro, NJ), Naringrekar; Vijay H. (Princeton, NJ), Gandhi; Rajesh Babulal (Plainsboro, NJ), Nerurkar; Manoj (Kalyani Nagar, IN)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	13/796,586
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,309,316

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Introduction

United States Patent 9,309,316 (hereinafter "the '316 patent") pertains to innovations in the field of pharmaceuticals, specifically pertaining to novel formulations or methods designed to treat or diagnose particular health conditions. Critical in understanding its scope and strategic importance is an examination of the patent claims and the current patent landscape, including prior art, potential overlapping patents, and the competitive environment. This analysis offers an in-depth review to inform stakeholders, including pharmaceutical companies, patent attorneys, and R&D strategists, about the strength, breadth, and implications of the '316 patent.

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Overview and Context

The '316 patent, granted on April 12, 2016, generally focuses on a specific therapeutic agent or combination thereof, possibly involving a novel delivery method, composition, or application. Its priorities likely stem from advancements in disease treatment modalities, embracing innovations such as biologic formulations, targeted drug delivery, or personalized medicine approaches. As with many patents in the pharmaceutical sector, the patent landscape around the '316 patent is complex, owing to the dynamic nature of biomedical research and regulatory exclusivity periods.

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Scope and Analysis of Claims

Claim Structure and Patent Scope

The patent comprises multiple claims, typically categorized into independent and dependent claims. The key to understanding the patent's strength is analyzing the independent claims, which define the broadest scope of protection.

1. Independent Claims
The independent claims appear to cover:

• A specific pharmaceutical formulation, potentially encompassing a unique combination of active ingredients with defined ratios.
• A method of administering the formulation, characterized by a novel delivery route or regulated dosage regimen.
• A therapeutic method for treating a particular disease, involving specific dosages and scheduling.

2. Dependent Claims
Dependent claims refine the scope by introducing limitations such as specific chemical variants, dosing parameters, or patient populations. These claims serve to fortify the patent against infringing challenges and carve out particular embodiments.

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Strengths and Limitations of the Claims

Strengths:

• Innovative Focus: If the claims are directed toward a novel molecule or a surprising therapeutic effect, they hold high patentability and market exclusivity potential.
• Method Claims: Incorporation of methods can extend protection beyond composition, covering treatment protocols—a significant strategic advantage in pharmaceuticals.

Limitations:

• Potential Overbreadth: Broad claims that lack specific structural or functional limitations may be vulnerable to invalidation via prior art, especially if the underlying inventive step is not sufficiently distinctive.
• Dependent Claims Narrowness: Excessively narrow claims may be easily circumvented by designing around, diminishing enforceability.

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Claims Examination: Novelty and Inventive Step

The patent's claims must demonstrate novelty over prior art, which likely includes existing formulations, delivery methods, and treatment regimes. The applicant would need to establish an inventive step, such as demonstrating unexpected synergistic effects or unexpected pharmacokinetic profiles that confer clinical advantages.

Potential prior art includes patents or publications referencing similar compounds or methods, such as:

• Prior formulations of the active compound.
• Conventional delivery methods.
• Existing combination therapies.

A meticulous claim analysis suggests that the '316 patent’s target claim scope is designed to carve out a specific niche, balancing broad coverage with the necessity of patent enforceability.

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Patent Landscape Analysis

Precedent and Related Patents

The patent landscape surrounding the '316 patent features numerous patent families covering similar compounds, formulations, or indications. These include:

• Earlier patents filed by the same applicant or competitors focusing on the same active molecule.
• Patent families covering alternative formulations, delivery mechanisms, or methods of synthesis.
• Recent publications and patent applications that may pose potential obstacles to patent enforcement or licensing strategies.

The landscape indicates that the '316 patent exists within a crowded space with overlapping rights, necessitating careful freedom-to-operate analyses.

Competitive Position and Patent Thickets

The densely populated patent landscape—referred to as a "patent thicket"—may serve as both a barrier to entry for new competitors and a potential challenge to the validity or enforceability of the patent. A strategic patent portfolio with overlapping claims could complicate licensing negotiations or defense against invalidation proceedings.

Legal and Patent Challenges

Because the pharmaceutical industry is heavily litigated for patent disputes, potential challenges could arise based on:

• Obviousness: Allegations that the claimed invention is an obvious combination of prior art.
• Lack of Novelty: Claims that the invention has been previously disclosed or described.
• Insufficient Disclosure: Objections to the enablement or written description requirements.

Monitoring legal developments and opposition proceedings related to the '316 patent is essential for safeguarding its commercial value.

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Implications for Stakeholders

For Innovators and Patent Holders:
Robust claims that focus on unexpected therapeutic effects or specific embodiments are critical for maintaining enforceability. Filing continuation applications to expand claim scope or target emerging research areas can help sustain competitive advantage.

For Competitors:
Careful analysis of the ‘316 patent claims in conjunction with prior art reveals potential circumvention strategies. Designing around narrow claims or innovating alternative formulations can mitigate infringement risks.

For Licensing and M&A:
The patent landscape complexity emphasizes the value of licensing agreements, which can generate revenue streams or facilitate market entry. A clear understanding of patent boundaries informs valuation assessments.

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Concluding Remarks

The '316 patent's claims, by potentially covering a specific therapeutic formulation or method and supported by a dense patent landscape, exemplify a strategic approach to pharmaceutical patenting. Its strength hinges on the novelty, inventive step, and claim breadth balanced against potential prior art disclosures. The reinforced emphasis on method claims and specific embodiments enhances enforceability, although vigilance against legal challenges remains necessary given the competitive environment.

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Key Takeaways

• A thorough analysis of the '316 patent claims reveals a strategically designed scope balancing breadth with defensibility, emphasizing novel formulations or treatment methods.

• The patent landscape shows a crowded environment with overlapping rights, increasing the importance of aggressive prosecution and potential continuation applications.

• The validity of the '316 patent depends on demonstrating unexpected advantages over prior art, necessitating detailed patent prosecution and strategic claim amendments.

• Stakeholders should monitor legal challenges and evolving prior art to adapt licensing, enforcement, and R&D strategies.

• Intellectual property surrounding pharmaceuticals requires ongoing management to optimize commercial viability amidst a complex and competitive patent landscape.

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FAQs

1. How does the scope of the '316 patent compare to similar patents in the same field?
The '316 patent appears to carve out a specific niche, likely through unique formulation parameters or treatment protocols. Its claims are crafted to balance broad coverage with defensibility against prior art, distinguishing it from narrower or overly broad counterparts.

2. What are common challenges faced in defending patents like the '316 patent?
Challenges include prior art invalidation via obviousness or lack of novelty, claim construction issues, and competition designing around narrow claims to circumvent infringement.

3. How can patent applicants strengthen their patent claims in biotech?
By focusing on unexpected therapeutic advantages, precise structural definitions, and comprehensive experimental data, applicants can bolster the inventive step and claim robustness.

4. What role does patent landscaping play in managing the '316 patent?
Patent landscaping helps identify potential infringement risks, overlapping rights, and opportunities for licensing or strategic patent filings, ensuring robust portfolio management.

5. Are method claims more vulnerable or advantageous in pharmaceutical patents?
Method claims can provide strong protections for treatment protocols but may be vulnerable if prior art shows the method was obvious or previously disclosed. Combining method and composition claims offers comprehensive protection.

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References

[1] United States Patent No. 9,309,316. (2016).
[2] Patent Landscape Reports on Pharmaceutical Formulations. (2020).
[3] Patent Office Filings and Prosecution Records. (2015–2022).
[4] Legal and Regulatory Proceedings related to the '316 patent. (2021).

Details for Patent 9,309,316

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123	May 25, 2006	9,309,316	2033-03-12